Below-the-knee prosthesis and method of making the same

ABSTRACT

A prosthesis for fitting a below-the-knee amputee is disclosed and includes a socket for receiving the stump of the below-the-knee amputee, a keel having a peripheral groove formed about the periphery of a bottom portion of the keel, a tubular shin member extending from the socket and surrounding lateral and medial portions of the keel and filling the peripheral grooves formed about the bottom portion of the keel leaving a substantial portion of the bottom of the keel exposed. A resilient foot member is then secured to the exposed portion of the keel with the material of the tubular shin member being formed into the grooves of the keel and maintaining such keel within the shin member. Also the method of manufacturing such prosthesis.

This is a divisional application of Ser. No. 493,454, filed Mar. 14,1990.

TECHNICAL FIELD

This invention relates to a below-the-knee prosthesis and method ofmaking the same. More particularly, this invention relates to alight-weight below-the-knee prosthesis having a foam keel portion suchthat a rubber foot may be readily adhered thereto.

BACKGROUND OF THE INVENTION

An artificial leg or prosthesis for a person who has a below-the-kneeamputation and has tissues which are sensitive to the pressures andfriction associated with the use of a prosthesis presents a significantproblem if reasonably full use of the knee is to preserved. As is thecase with conventional prosthesis, these artificial limbs are usuallyfitted to the stump of the leg below the knee and strapped to the legabove the knee so that use of the knee for walking may be preserved.However, because this limb is fitted to the stump and the stump and limbare not one in the same, significant stresses during movement of thelimb will tend to irritate the stump in the area where it contacts theprosthesis. Therefore, the need for a lightweight prosthesis is apparentparticularly when fitting very weak geriatric patients with this type ofprosthesis.

Numerous attempts have been made to develop a prosthesis which is bothlightweight and structurally sound in order to perform functions similarto that of the natural limb. Some of these attempts have included anarticulated toe and ankle section in an attempt to imitate nature byduplicating the functions of the natural foot. The importance of thecosmetic aspects of such an articulated limb are not to be denied,however, the simulation of these joints as well as that of the weight ofa natural leg results in a limb which is difficult to maneuver due to anextreme excess of weight. The prosthesis is not a natural limb and, asmentioned above, cannot function in all respects as a natural integrallimb.

In one attempt to overcome the shortcomings associated with the use of abelow-the-knee prosthesis is set forth in U.S. Pat. No. 3,909,855 issuedto Barredo. This below-the-knee prosthesis is a hollow rigid lightweightnon-articulated prosthesis having a foreshortened foot which is fittedto the stump of a below-the-knee amputee. This prosthesis is of aunitary hollow shell formed of fiber glass and includes a foreshortenedfoot. This foreshortened foot portion is shortened by a lengthapproximately equal to the toes of a natural foot and allows theprosthesis wearer to walk in a manner somewhat like that of a naturalwalk. However, the foreshortened foot exhibits no shock absorptioncharacteristics and therefore any shock to the foot portion of thisprosthesis will be absorbed completely by the stump of the wearer.Moreover, the foreshortened foot portion is not cosmetically pleasing toeither the wearer or others.

A currently favored simplification of the articulated toe and ankleprosthesis is that of a prosthesis having a solid ankle portion andcushioned toe, heel and sole attached thereto, commonly known as theSACH foot design which is fixed to the bottom portion of the prosthesis.

In previously known SACH-type prosthesis, the socket portion of theprosthesis was formed in a conventional manner. The socket may then beadhered to a copolymer prosthesis having a solid ankle portion.Initially, the copolymer completely encompassed the solid ankle andconsequently the cushioned or resilient heel was adhered directly to thebottom of the prosthesis, however, a reliable bond between the resilientheel and the copolymer prosthesis was not achievable due to the natureof the copolymer.

In order to overcome the above-mentioned problem, the bottom of thesolid ankle portion was left exposed; i.e., with no copolymer materialextending thereover and consequently a strong adhesion could be formedbetween the foam material of the solid ankle portion and the resilientmaterial of the heel portion. However, because a majority of the foam isremoved from within the prosthesis in order to significantly reduce theweight of the prosthesis, during use the keel would detach from thecopolymer material of the prosthesis and pull out of the prosthesisresulting in a separation between the resilient heel and the shinportion of the prosthesis thus resulting in a lack of confidence in thestructural integrity of the prosthesis. Additionally, because theprosthesis was susceptible to such structural damage, use of theprosthesis was limited to inactive below-the-knee amputees.

Clearly, there is a pressing need for a lightweight and structurallysound prosthesis that may be worn by both nonactive as well as activeamputees who can wear the prosthesis while performing any activitywithout fear of any catastrophic failures.

SUMMARY OF THE INVENTION

A primary object of the present invention is to overcome theabove-mentioned shortcomings associated with the previously knownprostheses.

A particular object of the present invention is to provide a lightweight prosthesis which may be worn by either an active or inactivebelow-the-knee amputee. This is achieved by removing substantially allof the foam material used to construct the support structure for moldinga shin portion of the prosthesis thereon. This is carried out bygrinding away from an interior of the shin member foam material whereinthe foam material is accessed from both the proximal and distal ends ofthe prosthesis.

Another object of the present invention is to provide a prosthesiswherein the fear of catastrophic failure of the prosthesis is virtuallyeliminated. This is carried out by forming a retaining means in the keelportion of the prosthesis such that material forming the shin memberwill essentially lock the keel within the shin so as to prevent the keelfrom pulling out of the shin member during use.

A further object of the present invention is to reliably secure aresilient foot to the bottom surface of the keel. This is carried out bytemporarily securing the foot to the bottom surface of the keel andforming channels about the periphery of the surface. These channels arethen completely filled with an epoxy resin which reliably maintains theresilient foot in place.

These as well as other objects of the present invention are achieved byproviding a prosthesis for fitting a below-the-knee stump including asocket for receiving the stump of a below-the-knee amputee, a keelhaving a peripheral groove formed about the periphery of a bottomsurface thereof as well as a transverse groove extending from a lateralperiphery of the keel to a medial periphery of the keel formed in thebottom surface. A tubular shin member extending from the socket meansand surrounding the keel with a portion thereof extending into theretaining means while leaving a substantial portion of the bottomsurface of the keel exposed and a resilient foot member secured to thisexposed bottom surface.

The above-mentioned prosthesis is formed in accordance with the presentinvention by forming a socket conforming to the stump of thebelow-the-knee amputee, constructing a shin support including an ankleblock and the keel in accordance with the size and stature of theamputee on the socket, machining a peripheral groove about the peripheryof the bottom surface of the keel and a transverse groove extending fromthe lateral periphery to the medial periphery of the keel and the bottomsurface thereof for retaining the keel in a predetermined position withrespect to a shin member, and molding a sheet of copolymer material,preferably polytetrabutylene about the shin support, and into theretaining means and over the bottom surface of the keel to form the shinmember. Next, all of the copolymer material is removed from the bottomsurface of the keel except for that portion which has been molded intothe grooves, a substantial portion of the material used to construct theshin support is removed from within the shin member and a resilient footis secured to the exposed bottom surface of the keel. Also formed inboth the lateral and medial sides of the keel are a plurality of boresfor receiving a portion of the molded sheet of copolymer material to aidin maintaining the keel in the predetermined position with respect tothe shin member.

The above, as well as other objects of the present invention, willbecome apparent from the drawings and detailed description set forthhereinbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view of a prosthesis in accordance with thepresent invention with the stump portion of a below-the-knee amputeeinserted therein.

FIG. 2 is a partially cross-section front elevational view of theprosthesis of FIG. 1.

FIG. 3 is an elevational view of a keel and ankle block portion inaccordance with the present invention.

FIG. 4 is a bottom view of the keel illustrated in FIG. 3.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to the drawings and particularly to FIG. 1, a prosthesis 2 isillustrated having a socket 4 for receiving a stump 6 of abelow-the-knee amputee. The prosthesis 2 of the present invention isformed of a 1/8" sheet of copolymer material, preferablypolytetrabutylene which is heated in an oven and formed about a mold.This process will be described in greater detail hereinbelow. Theprosthesis 2 includes the socket 4 for receiving the stump 6 and a shinportion 8 which extends downwardly from the socket and about an ankleblock 10 and keel 12 which are best seen in FIG. 3. Attached to thebottom of the keel 12 is a resilient OTTO BOCK™ No. 1S19 resilient heel,sole and toe section more commonly referred to as a foot 14. The foot 14is adhesively secured to an exposed bottom portion of the keel 12 whichwill be described in greater detail hereinbelow.

As can be seen from FIG. 2, the upper portion of the shin 8 is fixed tothe socket 4 in a conventional manner and extends downwardly therefromand about the ankle block 10 and keel 12. The ankle block 10 and keel 12are best illustrated in FIG. 3 wherein these members are illustrated asabutting one another at 17. During the manufacturing process of theprosthesis, a suitable ankle block 10 and keel 12 are selected inaccordance with the size of the amputee to be fitted. The ankle block 10is formed of OTTO BOCK™ Pedelin Foam No. 617H12 and Hardener No. 617P21as is the keel 12. As can be noted, the keel 12 takes the shape of theupper region of the foot and it is the lateral or outer side of the footthat is illustrated in FIG. 3. Once the appropriate sized ankle block 10and keel 12 have been selected, these members are fixed relative to oneanother and the ankle block 10 is trimmed to achieve a smooth transitionbetween the ankle block 10 and keel 12. These members are secured to oneanother in a conventional manner by way of an ankle bolt (not shown)inserted through the bolt hole 13 which is later removed when finishingthe prosthesis.

As can be noted from FIG. 3, and as is better illustrated in FIG. 4, agroove 18 is formed about the peripheral of the keel member with thisgroove being approximately 1/4" wide and 1/8" deep. The groove 18 is inthe form of a cut-out and extends about the entire periphery of thebottom of the keel 12. Also formed in the keel 12 is a transverse groove20 which extends from the lateral side 22 to the medial side 24 of thekeel. This groove is positioned approximately one inch posterior to theleading edge of the keel and is approximately 1/2" wide and 1/8" deep.These grooves may be easily formed in the foam material of the keel byway of a hand-held grinder; however, in order to minimize manufacturingcosts and time, these grooves may be either molded or machined into thekeel during its original manufacture. Also formed in both the lateralside 22 and the medial side 24 of the keel 12 are bores 26a through 26d.These bores are approximately 5/16" wide and 1/4" deep. While thepreferred embodiment illustrates a pair of bores on each of the lateraland medial sides of the keel 12, any number of such bores may beprovided so long as the structural integrity of the keel 12 ismaintained. With the particular pattern of grooves set forth in thebottom portion of the keel 12, raised portions 28 and 30 are formedwhich contact the foot 14 when such foot is positioned adjacent thereto.While in the preferred embodiment, only one transverse groove 20 isillustrated, any number of grooves may again be present so long as thestructural integrity of the keel 12 is maintained and a sufficientsurface area is provided for contacting the foot 14. The significance ofthe above-mentioned grooves 18 and 20 as well as the bores 26a-26d andthe raised surfaces 28 and 30 will become apparent from a discussion ofthe manufacturing process of the prosthesis set forth in greater detailhereinbelow.

As mentioned previously, the two major concerns of the prostheses is theeffective weight and structural integrity of the prosthesis. Byeffective weight, it is meant the actual distribution of the weight inproportion to the overall weight. For example, the more weight which isdistributed away from the socket 4 of the prosthesis, the greater theforce required to maneuver such weight. Therefore, it is not only theoverall weight of the prosthesis which is of concern, but effectiveweight thereof. The above-described 27 prosthesis achieves both of thesecriteria and is manufactured in the following manner.

Initially, a well-fitting positive mold of the residual limb of thebelow-the-knee amputee is formed in a conventional manner. Check socketsare often used to achieve this goal. The socket 4 is also manufacturedin a conventional manner from a PELITE® liner of 3/16" firm PELITE®which is heated and molded over the cast in the conventional manner witha nylon sheath being pulled over the PELITE® liner and sprayed withsilicone. Next, a 1/8" copolymer sheet, preferably of polytetrabutyline,is heated in an oven and subsequently draped over the cast which ispositioned in a horizontal manner with the interior of the mold facingdownward. This copolymer sheet is then seamed and vacuumed formed in aconventional manner to fabricate the socket. Excess plastic is trimmedabout the cast with scissors with the remaining seam being flattened byrolling a dowel across the seam while applying a suitable amount ofpressure. Care must be taken to assure that the area about the seam doesnot become excessively thin. The socket is then allowed to cool forapproximately 30 minutes. After such time, a small hole is drilled inthe distal end of the socket and an air gun is used to remove the socketand liner from the cast with a grinder being used to reduce the overallseam to approximately 1/16". It should be noted that by not stretchingthe copolymer material over the cast, once this material has set aminimal amount of shrinkage will be experience.

The thus-formed positive mold is then cleaned and all excess plastic isremoved. The cast is then placed distal end up in a pipe jig and a 5-plysock is then pulled over the cast. The plastic socket is then put backon the cast and a shin section is manufactured in the conventionalmanner using OTTO BOCH™ pedelin Foam No. 617H12 and a Hardener No.617P21. By positioning the socket on the cast, this will prevent anydistortions of the socket created by heat which is generated by thecuring foam. Once this foam mixture has cured, the socket may then beremoved from the cast.

An appropriate OTTO BOCH™ No. 1S19 foot with pedelin keel and ankleblock is then selected in accordance with the size and stature of theamputee to be fitted with the prosthesis. The now-formed shin and socketsection is then trimmed to an appropriate height and the ankle block isfitted to the distal end thereof in a conventional manner. Once this hasbeen carried out, the thus-formed prosthesis is then positioned on thepatient and any height or alignment changes can be made in the shinportion by cutting away portions of the foam and the subsequentre-attachment thereof. It should be noted that the foam material may bebrittle and that care must be taken during this stage of themanufacturing process in order not to damage the foam structure.

Once the prosthesis is properly fitted to the patient, the prosthesis isshaped and smoothed and a solution of liquid plaster of Paris is sizedover irregular areas of the limb. However, care must be taken so as toavoid the area 3 inches proximal to the ankle joint and any other areaswhere the cured plaster could not be readily removed as described below.

Once the prosthesis is properly shaped, the inside of the socket iscoated with Vaseline® and filled with plaster and a vacuum pipe isinserted therein in a conventional manner and let stand to cure. Thefoot section 14 is then removed from the keel 12 and the bottom of thekeel 12 is then machined in order to reach the configuration set forthin FIGS. 3 and 4 in accordance with a preferred embodiment of theinvention.

With a small hand-held grinder, a groove approximately 1/4" wide and1/8" deep is machined about the entire peripheral edge of the bottom ofthe keel as illustrated in FIGS. 3 and 4. Subsequently, approximately 1"posterior of the leading edge of the keel 12, a transverse grooveextending from the lateral side 22 of the keel 12 to the medial side 24of the keel 12 approximately 1/2" in width and approximately 1/8" deepis machined across the bottom of the keel 12. Again, the significance ofsuch grooves will become apparent from the below description. Next, apair of 5/16" diameter bores are drilled in both the lateral 22 andmedial 24 sides of the keel 12 to a depth of approximately 1/4". Thefirst holes 26a and 26c on either side of the keel 12 are drilledapproximately 1-2" anteriorly of the posterior of the keel 12 and thesecond holes 26b and 26d on either side of the keel 12 are positionedapproximately 2" anterior of the respective first hole.

Once the desired configuration of the bottom portion of the keel isachieved, the vacuum pipe is again inserted into a pipe jig in order tomaintain the prosthesis structure in a horizontal fashion with theanterior of the prosthesis facing upwardly. A knee-high stocking orother similar covering material is pulled over the prosthesis and tiedoff at the upper portion thereof. Any excess stocking accumulated at thebottom of the keel can be forced into the bolt hole 13. A sheet of 1/8"copolymer material, preferably polytetrabutylene, is heated to atemperature which renders such material pliable, is then positionedadjacent the prosthesis structure and subsequently vacuumed-formedthereover in a conventional manner. A seam is formed on the bottom ofthe keel and along the posterior section of the prosthesis. This seam isthen trimmed to within 1/4" and subsequently gently rolled with a dowelto form a smooth and inconspicuous seam. This material is then allowedto cool for approximately 12 hours before the excess plastic is removed.Once the material has cooled, all plastic which overlies the raisedportions 28 and 30 of the keel is removed while the material within thegrooves 18 and 20 remains. Further, plastic material will subside intothe bores 26a-26d. It can be noted that upon the conclusion of themanufacturing process, the plastic material which has been maintainedwithin the grooves 18 and 20 will securely retain the keel 12 portionwithin the now copolymer coated prosthesis.

The prosthesis is now in its final stages wherein the plaster is removedfrom within the socket and a 1" spade drill bit is used to drill up intothe prosthesis from the bolt hole 13 in order to remove as much of thefoam material from within the copolymer shell as possible. The drillingis continued upward through the distal end of the socket with care beingtaken so as to not contact the copolymer coating. All of the foammaterial is then removed from a point approximately 2" above the anklejoint seam 17 to the distal end of the socket. The already formed hole16 in the socket may be enlarged in order to facilitate removal of thefoam material. A router with a 40 grit cone can be used for quick andeasy removal of the foam material. Again, care must be taken in ordernot to excessively contact the interior of the copolymer shell of theprosthesis.

It should also be noted that all foam material which can be removedwithout jeopardizing the structural integrity of the prosthesis must beremoved in order to achieve as light a prosthesis as possible.

The exposed surfaces of the raised portions 28 and 30 are then sanded inorder to form a highly advantageous surface for adhering the foot 14 tothe bottom of the prosthesis. A plug having a diameter of approximately1" and a depth of approximately 5/16" and formed of PELITE® foammaterial is snugly forced into the keel hole in order to seal off thisopening. In a similar manner. a plug is placed in the bolt hole of thefoot in order to provide a smooth and congruent bottom surface thereof.

The foot 14 is then positioned on the keel section and temporarilysecured in place by masking tape or other suitable material. A channelis thus formed between the foot 14 and the keel 12 which readilyreceives adhesive material therein. The masking tape is wrappedsufficiently around the foot 14 in order to provide only one smallaccess opening to the channels in the heel region of the foot 14 whichare formed by the grooves 18 and 20, the foot 14 and the masking tape.This will allow the adhesive material to flow throughout the bondingsurfaces between the foot 14 and the keel 12. In accordance with thepreferred embodiment, a mix of R200 epoxy resin and hardener are usedfor this purpose. With the prosthesis positioned such that the toe ispointed in a downward direction, the adhesive is poured into the accesshole left adjacent the heel of the foot 14. The adhesive material willsettle throughout the channels, therefore, the adhesive must beperiodically refilled. Once this is completed the prosthesis in itspresent stage must be allowed to dry for at least 24 hours. Oncecompleted, any excess resin is removed and all of the surfaces of theprosthesis are smoothed by using a fine grit sandpaper resulting in asmooth and congruent prosthesis. The foot portion 14 may then be paintedany suitable color for cosmetic purposes. Further, cosmetic stockingscan then be put on the prosthesis for cosmetic improvement.

By manufacturing the prosthesis in accordance with the above-describedprocess, the overall weight of the prosthesis can be reduced from 31/2lbs. to 11/2-2 lbs. without sacrificing any structural integrity.Moreover, the user can be confident that the catastrophic failuresassociated with previous prosthetic devices will not occur regardless ofwhether the user is active or inactive.

While the invention has been described with reference to a preferredembodiment, it should be appreciated by those skilled in the art thatthe invention may be practiced otherwise and as specifically describedherein without departing from the spirit and scope of the invention. Itis, therefore, to be understood that the spirit and scope of theinvention be limited only by the appended claims.

What is claimed is:
 1. A method of manufacturing a prosthesis for abelow-the-knee amputee comprising the steps of;forming a socket forreceiving a stump of the below-the-knee amputee; constructing a shinsupport about said socket including an ankle block and keel inaccordance with the size and stature of the amputee about said socket;forming a retaining means in a bottom surface of said keel for retainingsaid keel in a predetermined position with respect to said socket;molding a sheet of copolymer material about said shin support, into saidretaining means and over said bottom surface of said keel to form a shinmember; removing the copolymer material from said bottom surface of saidkeel except for that portion which has been molded into said retainingmeans; removing a substantial portion of material used to construct saidshin support from within said shin member; and securing a foot member tosaid keel.
 2. The method as defined in claim 1, wherein said shinsupport is formed of a foam material.
 3. The method as defined in claim1, wherein said step of forming said retaining means includes machininga peripheral groove about the periphery of said bottom surface of saidkeel.
 4. The method as defined in claim 3, wherein said step of formingsaid retaining means further includes machining a transverse groove insaid bottom surface of said keel extending from a lateral periphery ofsaid keel to a medial periphery of said keel.
 5. The method as definedin claim 3, wherein said step of forming said retaining means furtherincludes drilling at least one bore in each of a medial and lateralsides of said keel.
 6. The method as defined in claim 3, wherein saidperipheral groove is approximately 1/4 inch in width and approximately1/8 inch in depth.
 7. The method as defined in claim 3, wherein saidtransverse groove is formed approximately 1 inch posterior of a leadingedge of said keel.
 8. The method as defined in claim 3, wherein saidtransverse groove is approximately 1/2 inch in width and approximately1/8 inch in depth.
 9. The method as defined in claim 1, wherein the stepof securing said foot includes the steps of temporarily adhering saidfoot to said keel thereby forming channels about a securing surface ofsaid foot and filling said channels with epoxy resin to permanentlysecure said foot to said keel.